Device for providing a sterile limited space for surgery

ABSTRACT

A device for introducing sterile instruments into an operation chamber or an instrument chamber comprises an introduction frame, a first roller and a second roller rotatable around their respective longitudinal axis and attached to the introduction frame such that the longitudinal axis of the first roller and the longitudinal axis of the second roller are parallel and the first roller and the second roller are movable along an axis extending perpendicular to their respective longitudinal axis. A distance between the first roller and the second roller is defined by a position of a movement of the first and second roller along the axis extending perpendicular to their longitudinal axes. The first and second rollers are biased to contact each other and may be moved along the axis to increase the distance to allow insertion of an instrument through a gap provided by the distance.

CLAIM OF PRIORITY

The present application is a divisional application of and claimspriority under 35 U.S.C. § 120 to co-pending, commonly assigned andrelated U.S. patent application Ser. No. 15/538,420, entitled “A Devicefor Providing A Sterile Limited Space for Surgery” filed Jun. 21, 2017,the entire disclosure of which is incorporated herein by reference, andfurther claims priority to and the benefit under 35 U.S.C. §§ 119(b),119(e), 120, and/or 365(c) to PCT/EP2014/079239 filed Dec. 23, 2014,entitled “A Device for Providing A Sterile Limited Space for Surgery,”the entire disclosure of which is incorporated herein by reference.

FIELD OF THE INVENTION

The invention relates to a device for establishing and maintaining asterile environment for conducting surgical procedures. In particular, atent-like device provides an interior space and is attachable to apatient's skin to allow surgical treatment of the patient. Severalaspects of the invention are directed to devices to be used inconnection with such a surgical procedure using the tent-like device.

BACKGROUND OF THE INVENTION

Today, in almost all applications of surgical invasive treatmentsrequiring a major incision in the skin of a patient which needs to bemaintained over a longer period of time, for example, for 30 minutes orfor several hours, such treatments are undertaken in an operating room.Such an operating room provides a controlled atmosphere and environmentas a whole and allows the patient to be positioned in a sterile spaceinside the operating room. Generally, this opens the possibility toconduct such a surgical invasive treatment without the risk of infectionof the patient following migration of bacteria in the course of theoperation. However, this must be considered a theoretical finding inview of the practical circumstances when conducting such a surgicalprocedure.

In practice, one major aspect for the success of such a surgicalinvasive operation with regard to being infectionless is the preparationof the patient and the preparation of the persons conducting theoperation, such as the surgeon and assisting personnel. Major effortsrequiring significant time are made to establish sterile surfaces of thepatient, the surgeon, and the assisting personnel and any devices, suchas instruments, handles of medical devices inside the operating room,and the like are employed to prevent any source of infection. However,in view of large medical devices, such as x-ray apparatuses, additionalimaging devices, and further pneumatically or electrically drivenapparatuses, such as the surgical illumination device and the like, acompletely sterile preparatory work on all these devices and surfaces isa rather difficult task and thus in single cases no such completedisinfection and sterile environment is reached.

The costs for building and maintaining such an operating room and alldevices inside said operation room and the costs for preparing andmaintaining such operating room and any such devices in a sterilecondition are high. Further, the preparatory work for a surgicaltreatment takes considerable time, thus not allowing a frequentprocessing of multiple surgical treatments in one operating room. Thisprovides a significant drawback in particular with regard to surgicalinvasive treatments wherein such treatments do not take much time and itthus would be desirable to conduct multiple, short time treatments inone operating room, one after the other without significant preparatorywork for disinfecting the room and the surfaces.

It is generally desirable to facilitate such invasive surgery treatmentwith regard to the preparatory work and to increase the safety againstinfections of the surgery's side in the course of such surgicaltreatments. Further, it is desirable to reduce the time and effort spentfor such a surgical treatment and, in particular, the time spent forpreparatory work for such surgical treatment to allow such invasivesurgical treatments to be conducted in an environment at lower costs andin shorter time periods.

WO 1986/006272 A1 discloses an isolator for use in surgery. The isolatorincludes an inflatable bag of flexible material and a device formaintaining a positive pressure in the bag. The inflatable bag can befixed to a patient and a surgeon can insert his hands into theinflatable bag to conduct a surgical invasive treatment inside said bag.Whereas such a bag having a positive pressure is considered to be safeagainst invasion of bacteria due to the pressure drop against theenvironment, the positive pressure inside said flexible bag isconsidered to bear on the risk of inducing embolism to the patient inthe course of the surgical treatment by effecting local clotting orcoagulation of the blood and pressing such clotted blood or thepressurized air directly into the body and the circular system of thepatient. U.S. Pat. No. 7,037,254 B2 discloses a further device having aninflatable plastic dome to establish a controlled surgery environment bysuch inside pressurized atmosphere.

The use of such inflatable designs made of flexible sheet material hasnot shown to provide significant improvement with regard to preparatorywork and conducting of surgical invasive treatment. As a first reasonfor this, the known devices require significant preparatory work on thepatient to establish the sterile environment inside the inflatable bag.Further, the preparatory work is further complicated with regard to theplanning of the treatment due to the fact that the surgeon is hinderedfrom introducing additional instruments into the inflatable bag once thesurgical treatment has started and is further hindered from removingtissue material or fluids out of the inflatable bag during the course ofthe surgical treatment. Thus, the approach of using such inflatable bagsdid not find acceptance in practice.

A further aspect considered as a significant drawback of such devicesfor establishing a local limited controlled atmosphere above a patient'sskin for such a surgical treatment is the preparatory work fordisinfecting the patient's skin. Such disinfection procedure oftenhinders a secure and rigid attachment of the inflatable bag to thepatient's skin and thus bears on the risk of leakage as a result fromthe disinfection procedure of the patient's skin.

A still further drawback related to surgical treatments in general andspecifically such surgical treatments using inflatable bags forestablishing a limited sterile space is the preparatory work of thesurgeon and assistant personal, in particular related to the gloves tobe used by the surgeon and the personal. It is known that when puttingsuch surgical gloves on the hands there is a significant risk ofcontaminating the exterior surface of the glove or damaging the glovedue to the difficult handling of the gloves and the thin elasticmaterial the gloves are made from. Further, it is known that taking offsuch gloves bears the significant risk of contamination to the user ofthe gloves from infectious substances attached to the exterior surfaceof the gloves.

In this regard, U.S. Pat. No. 2,741,410 discloses an apparatus forhandling contaminated gloves wherein a person may insert his hand withthe glove into a box to sealingly engage with the wrist of the personand a vacuum is applied to said box to release the glove from the handof the person. By this, the taking off of such gloves may befacilitated. However, the apparatus is bulky and requires significanttechnical means to allow taking off of such gloves. U.S. Pat. No.4,915,272 discloses a further, more compact apparatus for donning andremoving gloves by applying a vacuum to the exterior of the gloves.According to one embodiment, a device having a rigid perforated negativeform of a hand with increased dimension is used to insert a hand wearinga surgical glove into said form and to apply a vacuum to take off such aglove. However, whereas this device provides function for taking off thegloves in an efficient procedure, it is rather impossible to use such adevice for putting on gloves since a glove cannot be placed inside sucha negative form without a hand being inserted into the glove or theform, which is not possible.

A further problem related to sterile limited spaces established on apatient's skin for conducting invasive surgical treatment, is how toprovide or exchange surgical instruments and devices inside such limitedspace for conducting surgical treatments requiring a significant numberof such instruments and devices. Generally, any process of introducingsuch instruments and devices into the limited space inside such aninflatable bag is considered to potentially induce contamination of thesterile atmosphere inside the bag and thus should be avoided. Further,the arrangement of a large number of instruments and devices inside suchan inflatable bag is not possible due to the limited space and the rangeof motion of the surgeon for grasping such instruments.

It is a general object of the invention to provide an option forconducting invasive surgical treatments with less time spent forpreparatory work and less risk of infection for the patient. It is aspecific object of the invention to provide a device wherein theplanning and the logistics of such a surgical treatment can besimplified and is less sensitive to unforeseen events in the course of asurgical treatment.

SUMMARY OF THE INVENTION

According to the invention, these and other objects are solved by adevice for producing and maintaining a sterile surface on a patient'sskin comprising: a first frame having first frame elements encompassinga first inner operation opening allowing access through said first framefrom a top side of the first frame to a bottom side of the first frame,said first frame elements having a downward first adhesion surfaceincluding an adhesive material adapted to adhere said first adhesionsurface to the patient's skin. A first foil, attached to the first frameand extends across said inner operation opening. A fluid channel isprovided in said first frame, said fluid channel being in fluidcommunication with a connector for injecting fluid into said fluidchannel, wherein said fluid channel opens into a space between thebottom side of the first frame and the first foil to allow flooding of aspace defined between the first foil and the patient's skin if the firstframe is attached to said patient's skin.

According to this aspect of the invention, a specific device is providedwhich can be employed and used for producing a sterile surface on apatient's skin. The device comprises a first frame which can be composedof one single frame element which is bent to define a closed structurecircumscribing an inner operation opening. The first frame can in thesame way be composed of multiple components connected to each other todefine such a closed structure and to circumscribe said first inneroperation opening. The inner operation opening defines the area on theskin of the patient which is accessible for the surgeon to conduct thesurgical operation. The first frame elements have a downward adhesionsurface which may comprise an adhesive tape or any other adhesivematerial which is capable of establishing a safe and tight adhesive andsealed contact to the patient's skin. It is to be understood that thisadhesive contact must be releasable to allow removal of the first frameafter the end of the surgical operation. A first foil extends acrosssaid inner operation opening in such a way that said first foilcompletely covers the first opening. The first foil is attached to thefirst frame in a sealing engagement. Preferably, the first foil isflexible and further preferable the first foil is semitransparent ortransparent. Generally, the first foil has a lower surface facing to theskin in use of the device, which is adapted to not adhesively attach tothe skin such that a disinfecting agent can be inserted into the spacebetween the skin and the first foil.

In use of the device according to the invention, the first frame isattached to the patient's skin in an area circumscribing that skinregion wherein the incision for the surgical operation is to be made,such that this skin region lies in the first inner operation opening andis covered by the first foil. A fluid channel is included in said firstframe allowing access from outside of the first frame to the first inneroperation opening. A connector is provided allowing to insert a fluidmaterial, in particular a liquid disinfecting or sterilizing agentthrough said fluid channel. The fluid channel opens into a level whichis lying between the downward first adhesion surface and the first foilattached to the first frame. By this, a fluid can be inserted throughsaid fluid channel into a space which is defined by the first foil, thefirst frame and the skin of the patient if the first frame is attachedto said skin with the downward first adhesion surface. In use of thedevice, a disinfecting or sterilizing agent is injected via said fluidchannel into this space such that the whole space between the first foiland the skin of the patient encompassed by the first frame is floodedwith the sterilizing and disinfecting agent. This flooded condition maybe maintained for a certain period of time to make sure that the effectof sterilizing the skin surface and the downward surface of the firstfoil is fully accomplished. Thereafter, the fluid is withdrawn which canbe accomplished by applying a suction force to the fluid channel andthus withdrawing the fluid out of the space between the first foil andthe skin. The process may be repeated once, twice or more, such that asafe sterile condition is produced. Hereafter, the fluid channel may beused to ventilate sterile filtered dry air through the space between thefirst foil and the skin to facilitate a fast drying of the space.Hereafter, the fluid channel may be closed by a plug or the like, beinginserted into the connector and the surgical operation can be started.

In a simplified setup, the surgeon may hereafter cut out the first foilor the first foil may be designed in such a way as to attach to the skinafter the sterilizing fluid has been removed such that the surgeon mayuse the first foil as a protective foil attached to the skin and cut thefirst foil like the skin in the course of the operation.

According to a preferred embodiment, the first foil comprises a removalextension for removing the first foil, the device further comprising: asecond frame having second frame elements encompassing a second inneroperation opening; a second foil, attached to the second frame andextending across said second inner operation opening; said second framehaving an outer dimension such that the second frame fits into the firstframe; said second frame elements having a downward second adhesionsurface including an adhesive material adapted to adhere said secondadhesion surface to the patient's skin upon removal of the first foil.According to this preferred embodiment a second foil is provided and thefirst foil is adapted to be removed by simple means like a graspingsection, a handle or the like. The second foil is attached to a secondframe and this second frame circumscribes a second inner operationopening. The second inner operation opening is almost completelycongruent to the first inner operation opening such that the secondframe fits into the first frame. The second frame is movable in relationto the first frame and in a first relative position to the first framethe second frame, the first frame, the first foil and the second foilsealingly enclose an inner space and said inner space is sterile. Aftersterilizing the skin of the patient via the flooding operation asdescribed beforehand, the first foil can thus be removed and by thissaid inner space opens to the skin. Due to the sterile nature of saidinner space the sterile condition of the skin is maintained by this. Thesecond frame can then be moved in relation to the first frame and herebythe second foil is brought into contact with the skin. The second framehas a downward second adhesion surface which can be adhered to thepatient's skin or can alternatively be adhered to the first frame. Bythis, the second frame and the second foil can be fixed in relation tothe skin. Preferably, the second foil has a downward adhering surfacefor adhering to the skin and is configured to be a protective foil ascommonly used in surgical operation to protect the skin around anincision of a surgical operation. Using this preferred embodiment thusallows to safely and conveniently use and apply such a protective foilin the course of the preparatory work of sterilizing the patient's skinand preparing it for the surgical operation.

According to a further preferred embodiment, the second foil has abottom surface facing towards a bottom side, wherein said bottom surfaceis coated with a first adhesive material adapted to attach said secondfoil, preferably a center region of said second foil to the skin of thepatient, wherein preferably an edge region of said second foil isreinforced and/or is coated with a second adhesive material havingstronger adhesive properties than said first adhesive material.According to this preferred embodiment, the second foil acts andfunctions as a protective foil to the skin of the patient in the regionof the incision of the surgical operation. Further, the second foilestablishes a safe sealing contact in an edge region close to the secondframe preventing migration of any gaseous or liquid fluid or the likefrom outside the frame into the operation site and the incision region.Preferably, the adhesive material is applied in a pattern in the edgeregion which is different from the pattern in which it is applied in thecentral region of the second foil. Alternatively the adhesive materialapplied in the edge region of the second foil may be a differentadhesive material than the adhesive material applied in the centralregion of the second foil.

According to a further preferred embodiment, a second fluid channel isprovided in said first frame, said second fluid channel being in fluidcommunication with a second connector for removing fluid out of saidsecond fluid channel, wherein said second fluid channel opens into saidspace between the bottom side of the first frame and the first foil toallow flooding of said space defined between the first foil and thepatient's skin if the first frame is attached to said patient's skin.According to this embodiment, a second fluid channel is provided in saidfirst frame and thus the insertion and the removal of the sterilizingagent is simplified in that the fluid may either be inserted via twochannels, for example at opposed sides of the frame and thereafterwithdrawn via said two channels or in an alternative procedure the agentmay be inserted via the first fluid channel and may be withdrawn throughthe second channel. According to this embodiment, the connector providedfor the first fluid channel and the connector provided for the secondfluid channel might be identical but in specific applications, whereinthe first channel serves to insert the sterilizing agent and the secondchannel serves to withdraw the sterilizing agent. The connectors may bedifferent to prevent misuse of the connectors and the fluid channels. Itis generally to be understood that both the first and the second fluidchannel might include a check valve closing the fluid channel against aspecific flow direction and might further include a valve which ispushed open by inserting a cannula, hollow needle or the like and whichis closing the fluid channel upon removal of such cannula or needle.This will safely prevent migration of any fluids or bacteria through thefluid channel into the surgical site. In particular, this allowseffective drying via continuous venting of the space and the skin andfoil surfaces with dry air or the like.

According to a further preferred embodiment, a first fluid channel opensinto said space on a first side of the frame and said second fluidchannel opens into said space on a second side of the frame, which isopposite to said first side. According to this preferred embodiment, inboth optional uses, i.e. insertion of the sterilizing agent via bothfluid channels and withdrawing of said agent via both channels oralternatively insertion of the sterilizing agent via one fluid channeland withdrawing of the agent via the second channel, this can beconducted in such a way that complete coverage of the skin under thefirst inner operation opening is ensured by a specific oppositearrangement of the fluid channels.

According to a still further preferred embodiment, the first foil orsaid second foil is attached to a collapsible frame, wherein saidcollapsible frame in a first, upright condition defines side walls of aspace having a cross section generally corresponding to said first orsecond inner opening, respectively, and wherein said collapsible framecan be collapsed to a second condition, wherein said collapsible frameis lying flat on said first or second foil, respectively, and protectsan edge region of said foil against mechanical impact. According to thisembodiment, a collapsible frame is provided, wherein said collapsibleframe can be part of the first frame or part of the second frame or thefirst frame or the second frame can even be constituted by saidcollapsible frame. The collapsible frame in a first condition defines aspace versus the skin and can be collapsed down to a second condition,wherein the collapsible frame lies flat on the skin or on said first orsecond foil in the edge region of the inner operation opening. By this,this edge region is sealed as a first function and is protected againstincisions as a second function of the collapsible frame. It is to beunderstood that the collapsible frame preferably collapses in such a waythat a sterile surface of the frame faces towards the operation siteboth in the first and the second condition such that no adverse effectsoccur in the course of the collapsing of this collapsible frame.

According to a further aspect of the invention, an assisting device fordonning and removing a surgical glove is provided, said assisting devicecomprising: at least one fluid-tight wall arrangement, encompassing aninner space having a volume of such a size that at least a palm portionand finger portions of said surgical glove can be arranged in saidspace; an opening adapted to sealingly engage a cuff portion of saidsurgical glove if said palm portion and said finger portions arearranged in said space; characterized in that said fluid tight wallarrangement is adapted to be transformed from a first configuration intoa second configuration and vice versa, wherein in said firstconfiguration said inner space has a first inner volume; and in saidsecond configuration, said inner space has a second inner volume,wherein the first volume is smaller than the second volume.

According to this aspect of the invention, a functional and simplifieddevice is provided which allows a surgeon or any personal involved in asurgical operation a facilitated taking on and taking off of a surgicalglove. The device comprises a fluid-tight wall which defines an innerspace in a sealing arrangement. Said inner wall can be comprised fromone single flexible wall element or by two or more wall elementsconnected with each other to circumscribe and seal said inner space. Theinner space defined by said wall is dimensioned such that a hand can betaken up by said inner space and some clearance is provided between thehand and the wall if the hand is inserted into the inner space. Anopening is provided at said wall allowing access to the inner space andsaid opening has a dimension such that a hand can conveniently reachthrough said opening into said inner space. The opening is adapted tosealingly engage a cuff portion of a surgical glove. This can beaccomplished in a simplified way in that the cuff portion is put over anedge region of the wall circumscribing said opening by a sort of reversedrawing or the like. In other embodiments, the cuff portion of the glovemay be clamped between an edge region of the wall close to the openingand an inner ring inserted into the cuff portion of the glove to providesuch sealing engagement. By sealingly engage a glove in such a way tothe opening a sealed space between the glove and the wall is establishedinside said inner space.

According to the invention, the fluid-tight wall can be transformed froma first configuration into a second configuration and vice versa. Thistransformation can be conducted by elastic deformation of the wall or bya relative movement of two wall elements versus each other or the like.Generally, the volume inside the fluid-tight wall is different in thefirst configuration versus the second configuration, such that thevolume inside the fluid-tight wall is larger in the second configurationthan in the first configuration. By this a specific effect occurs inthat the sealed space between the fluid-tight wall and the glove isincreased when transforming the fluid-tight wall from the firstconfiguration to the second configuration and by this an extension forceis applied to the glove by a vacuum applied to the outer surface of theglove facing towards the fluid-tight wall. By this, the glove isextended homogeneously and thus a surgeon or an assistant personal mayeasily slide his or her hand into the surgical glove to take off theglove. In the same way, a person wearing a surgical glove may insert hisor her hand into the inner space, establish a sealing engagement in thecuff region of the glove/the hand and thereafter transform thefluid-tight wall from the first configuration into the secondconfiguration to apply a vacuum to the outer surface of the glove. Bythis, the glove will be extended and will be lifted from the skin of thehand and at the same time will be held back inside the inner space ifthe person withdraws his/her hand out of the inner space thereafter. Bythis, the person may easily take off the surgical glove using the deviceaccording to the invention.

According to a first preferred embodiment, said wall arrangementcomprises at least one flexible wall section, and wherein in said firstconfiguration said flexible wall section has a first shape, thusdefining said first inner volume; and in said second configuration saidflexible wall section has a second shape, thus defining said secondinner volume. According to this embodiment, the first and secondconfiguration is accomplished by transforming the fluid-tight wall by aflexing motion and thus a reversible, elastic deformation of thefluid-tight wall is conducted to transform the fluid-tight wall from thefirst configuration into the second configuration and vice versa.According to this embodiment, the fluid-tight wall might have a flatelliptic cross-section in the first configuration and may be transformedinto the second configuration having a cylindrical cross-section andthus an increased inner volume wherein one front face of saidelliptical/cylindrical tube may be sealed by a flexible foil and theother front face may provide the opening for inserting the glove and thehand.

Still further, it is preferred that said flexible wall section is biasedinto said first shape, or said flexible wall section is biased into saidsecond shape. According to this embodiment, the fluid-tight wall has apreferred configuration, either the first or the second configurationand thus is configured in said preferred configuration if no outer forceis applied to the fluid-tight wall and can be transformed into the otherconfiguration by applying such a force.

According to a further preferred embodiment, the assisting device isfurther improved by a second flexible wall section, wherein said secondflexible wall section is coupled to said first flexible wall sectionalong two opposed edges of said first and second flexible wall sections,wherein in said first configuration the first and second flexible wallsections form a flat pocket-like geometry with the first inner spacebeing inside the pocket and in said second configuration said first andsecond wall section are bent outward to both form outer convex surfaces.According to this preferred embodiment, the fluid-tight wall is definedby two wall sections lying parallel to each other and having identicalor almost identical dimension such as to form a pocket-like arrangement.In such a configuration, the two wall sections are connected at theopposed side edges to each other such as to allow a relative movement inthe form of a hinge-like connection in these side edge regions, inparticular, the two flexible wall sections may be connected by anintegral hinge at the side edges. The front edges of the wall sectionsmay define the edges around the opening into the inner space. The rearedges may be connected by an integral hinge in the same way as the sideedges or may be sealed against each other by a flexible foil or the likeconnected to the rear edges of the wall sections such as to allow therear edges to separate from each other into the second configuration.Such a pocket-like design of the assisting device thus provides a first,flat configuration with a small or zero inner volume and may easily betransformed into the second configuration by applying a pressure forceonto the two side edges forcing the two wall sections apart and thustransforming the assisting device into a sort of elliptical orcylindrical cross-sectional geometry with a significantly increasedinner volume. It is to be understood that instead of the fluid-tightwall comprising two such wall sections in further improved embodiments 3or 4 such wall sections may be provided which are sealingly connected toeach other via integral hinges or the like to provide the samefunctionality.

According to a further, alternative preferred embodiment, the assistingdevice is further improved in such a way that said fluid-tight wallarrangement comprises a first tube segment and a second tube segment,said second tube segment being slidable attached to a first ring segmentso as to form a telescope-like arrangement, wherein said second tubesegment can be slid into a fluid-tight sealing engagement towards anouter surface of said first tube segment; wherein the second ringsegment can be slid onto said first ring segment in an axial directionfrom said first configuration into said second configuration, and insaid first configuration the total length in the axial direction of thefluid tight wall arrangement comprised of said first and second ringsegment is shorter than in said second configuration.

According to this preferred embodiment, the fluid-tight wall arrangementcomprises two wall segments which are shaped as a tube wherein thesecond tube segment has an inner dimension adapted to conform to anouter dimension of said first tube segment such that the second tubesegment can slide on the outer surface of the inner tube segment. Thissliding movement shall be a sealing sliding movement such that the innerspace defined by the first and the second tube segment is always sealedagainst the environment even such that no fluid may flow through thecontact region between the first and the second tube segment. It is tobe understood that the invention may comprise a further third tubesegment or even further additional tube segments wherein such third tubesegment may be adapted to sealingly slide on the outer surface of thefirst tube segment or on the outer surface of said second tube segment.The first and second tube segment and potentially further tube segmentssuch define a telescope-like arrangement allowing to arrange the tubesegments in a first, short configuration wherein the first and thesecond tube segment overlap each other over a significant length and asecond configuration having an elongated dimension wherein the overlapof the first and the second tube segment is significantly less than inthe first configuration. By such a sliding movement the fluid-tight wallarrangement composed of the first and second and optionally further tubesegments can easily be transformed from a first configuration into asecond configuration wherein the inner volume is significantly increasedby such sliding movement of the tube segments versus each other. In thispreferred embodiment, one front end of a tube segment may serve as theopening to insert the glove and the hand into the inner space inside thetube segments and the other, rear end of the other tube segment may besealed wherein such sealing shall not be flexible but a rather stiffsealing wall may be provided such that one of the two tube segments mayhave a cup-like configuration with the bottom of the cup forming thesealing rear end wall.

According to a further preferred embodiment, said fluid-tight wallarrangement comprises an elastic tube segment which can be elasticallydeformed from an elliptic cross-sectional shape in said firstconfiguration to a circular cross-sectional shape in said secondconfiguration.

According to a still further preferred embodiment, a fluid-tight seal isprovided for providing said sealing engagement of said opening and saidcuff portion, the fluid tight seal comprising a strap having an outerring, an inner ring and at least one snap ring; wherein the at least onesnap ring is adapted to secure the cuff portion of said surgical glovebetween an inner surface of the outer ring and an outer surface of theinner ring, said outer ring having an outer surface which can bepartially inserted into said opening to sealingly engage said opening.

According to this preferred embodiment, a specific and convenient use isprovided for the fluid-tight seal of the glove versus the opening in thecuff portion of the glove. This convenient sealing engagement isestablished by two rings wherein one of the two rings is an outer ringand arranged on the outside surface of the glove and the other ring isan inner ring arranged on the inner side of the glove and inside theouter ring. Thus, the outer surface of the inner ring is dimensionedsuch as to engage the inner surface of the outer ring and it is to beunderstood that a slight clearance might be present but a slight overlapmay be possible, too with regard to the dimension of the outer surfaceof the inner ring and the inner surface of the outer ring as long as atleast one of the two rings can be elastically deformed. Further, a snapring is provided and this snap ring is adapted to apply a radiallyoutwards directed force onto the inner ring to press said inner ringagainst said outer ring. By this, a glove can be safely and sealinglyengaged between the inner and the outer ring. Further, the arrangementof the inner and outer ring with the glove clamped between the two ringscan easily be sealingly engaged to the opening and thus, the use of theassisting device is further facilitated and made more convenient for asurgeon or assistant personal. Preferably, the outer ring may compriseone or two circumferential lamellae to sealingly engage an inner edgeregion of the fluid-tight wall close to the opening to establish suchsealing engagement to the fluid-tight wall.

According to a still further preferred embodiment, said inner spacecomprises a first region adjacent to the opening and adapted toaccommodate the palm portion of the surgical glove and a second regionadjacent to the first region and adapted to accommodate the fingerportions of the surgical glove, wherein in said first region the wallarrangement restricts the elastic stretching of the glove in the secondconfiguration such that the palm region is stretched to an extent ofless than 150%, preferably less than 125%, wherein said elasticstretching is restricted by a contact of an inner surface of said wallarrangement to said surgical glove in said first region. The inventorhas found that some embodiments of surgical gloves show a significantextension in the palm region when applying an internal pressure into theglove or applying an external vacuum to the glove and this extension inthe palm region is significantly higher than the extension in the fingerregion of the glove. The reason for this behavior can be found in thehigher resistance and mechanical stability against deformation in thefinger region than in the palm region of the glove. However, thisbehavior was found to be unfavorable when using such gloves inconnection with the assisting device according to the invention, since aperson may easily access the palm region of the glove, but may haveproblems when putting his fingers into the finger regions of the gloveor removing his fingers out of the finger regions of the glove. Thus,according to this embodiment, the elastic deformation, this means theextension of the glove in the palm portion, is limited by the wallarrangement to a certain extent. This can be easily accomplished in thatthe palm portion of the glove abuts the inner surface of the wallarrangement when having reached a certain degree of extension.Hereafter, the palm portion of the glove is hindered from being furtherstretched or extended and thus the vacuum being applied to the glovewhen the sealing wall arrangement is further transformed into the secondconfiguration will only apply an extension force to the finger portionsof the glove. By this, a significant extension of the finger portionscan be reached such that in an ideal setup both the palm portion and thefinger portion are extended by a similar ratio and thus a user mayconveniently insert or withdraw his/her hand into the glove or out ofthe glove in the such extended configuration.

It is to be understood that the assisting device according to theinvention has a major advantage over prior art devices in that noexternal vacuum source like a vacuum pump or the like is required to usethe device. Thus, the assisting device according the invention can beused in a closed environment and does not require any input of energy orthe like to help a person in taking on or off surgical gloves. Inparticular, the assisting device can be used inside an inflatable bagarranged above a surgical site on a patient's skin and is completelyindependent from any pressure or vacuum condition inside such inflatablebag. It is further to be understood that the assisting device accordingto the invention may be a simplified disposable device equipped with oneglove and can as such a device be provided inside a pre-packed packageof such an inflatable bag to simply allow a surgeon to take off a gloveprovided inside the assisting device without the need for any help by anassisting personal or the like.

According to a further aspect of the invention, an isolation device forproviding a sterile operation chamber above a skin region of a patientis provided, in particular for performing a surgical procedure, saidisolation device comprising a first inflatable bag, the first inflatablebag delimiting said sterile operation chamber against the ambientenvironment. The first inflatable bag comprises a first and a secondaccess opening to allow a user to insert a first and a second arm intothe operation chamber, and a chamber operation opening to allow accessto said skin region of the patient out of the operation chamber, and awindow for observing handling operations inside said sterile operationchamber. The first inflatable bag is coupled to a support frame, thesupport frame having a transport configuration and an operationconfiguration. In the transport configuration, the first inflatable bagis confined, such as to have compact dimensions, and in the operationconfiguration, the first inflatable bag is extended, such as to formsaid sterile operation chamber.

According to this aspect of the invention, a specific device is providedwhich allows to define and to confine a sterile space of limited sizeabove a skin region of a patient. This sterile limited space can beaccessed by a surgeon and by assistant personal through openings in theinflatable bag, whereby it is to be understood that such openings may beclosed by elastically deformable means or a sealed glove withelongated/cuff arm sleeve may be attached to such an opening and aperson reaching into the inner space of said inflatable bag may put hishand and arm into such sleeved glove. It is to be understood thatfurther such openings may be provided in said inflatable bag, e.g., oneor two additional pairs of such openings for assistant personnel.

Generally, the inflatable bag is comprised of a flexible sheet materiallike a flexible foil or the like. The flexible bag may besemitransparent or transparent to allow a person to watch and observeany handling operations inside said flexible bag and to provide a goodillumination inside said bag by outer light sources arranged outsidesaid inflatable bag. In particular, by such transparent properties awindow may be provided in said inflatable bag but alternatively, suchwindow may be inserted into a flexible bag made of a non-transparent orsemitransparent material to allow visual inspection of the interior ofthe bag by a person from outside. In addition, said window mayspecifically be tailored to fit on imaging devices, like microscopes orother optical systems like cameras or an additional window for suchpurpose, may also be provided. Such window may comprise an adaptor ringwhich can be coupled to the objective of the imaging device.

The inflatable bag is connected to a support frame wherein said supportframe may comprise a single or a plurality of frame members. The supportframe may be arranged outside the flexible bag or inside the flexiblebag and, in particular, if the support frame is arranged inside theflexible bag, the coupling of the support frame and the flexible bag maybe comprised of a simple form locking arrangement of the flexible bagaround the support frame without particular connections between thesupport frame and the flexible bag to allow a limited relative movementof the flexible bag versus the support frame. The support frame isintended to establish an operation configuration wherein a sterileoperation chamber is formed inside the inflatable bag. In this operationconfiguration, the support frame provides a scaffold-like function tospan the flexible bag into a tent-like configuration which may have atube form, a bow form or the like. By this, an inner space is providedindependently from any specific pressure condition like an increasedpressure inside the bag and is maintained independently from anypressure source like a pressure pump, or the like. The sterile airvolume in the inner space is drawn and released passively overappropriate sterile (HEPA or similar) filters by the expansion andcollapsing of the support frame. The support frame can be collapsed to atransport configuration, wherein the inner volume inside said inflatablebag is significantly reduced, in particular collapsed to an inner volumeclose to zero such that in the transport configuration, the wholeisolation device has a compact design such as a flat design which caneasily be transported. To allow such collapsing from the operationconfiguration into the transport configuration the support frame may bemade from elastically deformable frame members or may comprise stiffframe members connected to each other via elastically deformable hingesor the like. In particular, the support frame may comprise frame membershaving a biased cross-sectional configuration which can be transformedinto a cross-sectional configuration allowing simplified bending of theframe members such as to establish a stiff, rigid support frameconfiguration in the operation configuration and a flexible, confinedsupport frame configuration in the transport configuration.

It is to be understood that the isolation device may preferably becoupled to a sterilizing device as described beforehand. Such acombination of the isolation device and the sterilizing device may beprovided as a package, e.g., a package with the isolation device in aconfined, packed condition attached to the first or second frame. Bythis, the upper surface of the first or second foil is kept in a sterileenvironment and thus, a surgical treatment can immediately be startedright after expanding the inflatable bag and disinfecting the skin.

According to a first preferred embodiment, support frame compriseshollow support frame members having at least one connector forintroducing a fluid material into said support frame members, wherein insaid transport configuration, said support frame members are deflatedand slack and in said operation configuration said support frame membersare inflated to a pressurized state such that the support members arerigid, or in said transport configuration, said support frame membersare deflated and slack and in said operation configuration a curableliquid is inserted into said support frame member, said curable liquidbeing cured to a hardened condition. According to this embodiment, thesupport frame comprises or is composed of one or a plurality of hollowframe members and these hollow frame member(s) is deformable and slackin a deflated condition wherein no or low pressurized fluid is insidesaid hollow frame members and a rigid or stabilized condition, whereinthe hollow frame members may be brought into a stiff and rigidconfiguration by two alternative functional measures. According to afirst alternative, the hollow frame members are inflated by apressurized fluid like a gaseous fluid, for example pressurized air, andthus are pumped into a stiff and rigid form. According to a secondalternative, a curable fluid like a polymer liquid is inserted into thehollow frame members and undergoes a curing action, for example by achemical reaction of said polymer liquid thus hardening inside thehollow frame members. This curing action may include a slight orsignificant expansion inside the hollow frame members thus furtherenhancing the stability of the support frame.

It is to be generally understood that the support frame may comprise onesingle or a plurality of support frame members wherein such plurality ofsupport frame members may be interconnected with each other such thatthe pressurized fluid or the curable fluid may be inserted into allsupport frame members via one single connector only. In otherembodiments, two or more support frame members may be provided eachhaving a separate connector for inserting said fluid into the supportframe members.

According to a further preferred embodiment of this aspect of theinvention, said support frame is formed by a plurality of elasticallyjoined rigid support frame elements. According to this embodiment, aplurality of stable and indeformable frame elements is provided whichare joined to each other by swivable elastically deformable joints. Itis general to be understood that according to the invention anelastically deformable material or component is understood as acomponent which can be transformed by a reasonable force from onegeometrical configuration into a different geometrical configurationwithout damaging the material, whereas a rigid or stiff material orcomponent is understood as a material which resists such deformation upto a significant force applied to the material/the component and will bedamaged if loaded over such force and be deformed thereby.

According to a further preferred embodiment, in said operationconfiguration said support frame elements comprise a middle supportframe element such as to support the inflatable bag in a middle sectionbetween the first and second access opening; a bottom support frameelement arranged below the first and second access opening, and a topsupport frame element arranged above the first and second accessopening. According to this embodiment, a specifically preferredgeometrical configuration of the support frame is provided which allowsa wide range of motion of a person conducting a surgical operationinside said inflatable bag by reaching his both arms through the firstand second access opening. To this regard, the support frame is composedof a middle support frame element between the first and second accessopening and a bottom and a top support frame element, wherein thesebottom and top support frame elements are arranged below and above theaccess openings, respectively. In particular, this embodiment may becomposed of two ring-like elements or open ring-like elements formed asC-elements in a symmetrical arrangement and being arranged around thefirst and the second access opening.

According to a still further preferred embodiment, the isolation deviceis further improved by an instrument chamber separate from saidoperation chamber and enclosed by a second inflatable bag coupled to asecondary support frame, wherein a transfer port is provided between theoperation chamber and the instrument. According to this preferredembodiment, a second inflatable bag is provided which encloses an innerspace serving as an instrument chamber. This second inflatable bag mayhave access openings for the arms of assistant personal to sort and grabthe instruments and to don such instruments to a surgeon conducting asurgical operation in the first inflatable bag. To allow such donningand receiving interaction between the assistant personal's hands insidethe second inflatable bag and the surgeon's hands inside the firstinflatable bag a transfer port is provided between the first and thesecond inflatable bag. Such transfer port may be defined by a frameelement in the first inflatable bag and a corresponding frame element inthe second inflatable bag wherein the two frame elements can besealingly coupled to each other to define an inner opening between thetwo frame elements serving as a transfer port. Preferably, the frameelements define such an inner transfer opening which is initially closedby a foil such that the first inflatable bag and the second inflatablebag independently from each other define a sterilized inside volume andcan be coupled to each other without the risk of migration of anynon-sterile fluid into said interior space. After having been coupledsealingly to each other the foils closing the transfer port inside theframe elements may be removed or cut such that instruments or the likecan be reached through the transfer port.

According to a further preferred embodiment the first inflatable bagcomprises an operation chamber connection frame encompassing anoperation chamber transfer opening; the secondary inflatable bagcomprises an instrument chamber connection frame encompassing aninstrument chamber transfer opening; wherein an operation chambershutter foil is attached to the operation chamber connection frame, suchas to provide a fluid-tight sealing of the operation chamber transferopening; and an instrument chamber shutter foil is attached to theinstrument chamber connection frame, such as to provide an fluid-tightsealing of the instrument chamber transfer. This specific embodimentallows for independent sterile inside volumes or spaces in the first andthe second inflatable bag and a safe connection of such two separateinside volumes after coupling of the first and the second inflatablebag.

According to a further preferred embodiment, the operation chamberconnection frame comprises an operation chamber connection surfacefacing the instrument chamber connection frame. The instrument chamberconnection frame comprises an instrument chamber connection surfacefacing the operation chamber connection frame, wherein the operationchamber shutter foil comprises a operation chamber shutter protrusion.The instrument chamber shutter foil comprises an instrument chambershutter protrusion. When the operation chamber connection surface andthe instrument chamber connection surface are brought into fluid-tightcontact and the operation chamber shutter foil and the instrumentchamber shutter foil are removed by means of the operation chambershutter protrusion and the instrument chamber shutter protrusion,respectively, the operation chamber transfer opening and the instrumentchamber transfer opening form the transfer port between the operationchamber and the instrument chamber. This further preferred embodimentallows for a convenient opening and closing of the transfer port betweenthe operation chamber and the instrument chamber and thus allows safecoupling and decoupling of the instrument chamber to the operationchamber. The option to close the transfer port after it had been openedto handle instruments trough the transfer port allows a decoupling ofthe instrument chamber and a coupling of a different instrument chamberto the operation chamber in the course of a surgical operation in orderto provide new or different instruments to the surgeon depending on theneeds and requirements of the ongoing surgical operation.

According to a further preferred embodiment, the operation chamberconnection frame comprises at least one connection protrusion, extendingfrom the operation chamber connection surface along a directionsubstantially perpendicular to the plane that is defined by theoperation chamber connection frame; and wherein the instrument chamberconnection frame comprises at least one connection groove, adapted toreceive the at least one connection protrusion. According to thisembodiment, a safe handling and a form locking engagement of the supportframe of the operation chamber with the support frame of the instrumentchamber is established thus preventing false arrangement and couplingaction of the chambers.

According to a further preferred embodiment, a plurality of lightsources is arranged at the support frame, in particular partiallyintegrated into the support frame. According to this preferredembodiment, a direct illumination inside the inflatable bag is providedby illumination devices like LED light sources attached to or integratedinto the support frame. This allows a convenient and strong illuminationinside the inflatable bag without the risk of having shaded regions.According to the invention, an energy source for supplying energy to thelight sources can be integrated into the isolation device, in particularcan be integrated into the support frame to provide an independentisolation device from any other energy sources. Alternatively, anelectrical connector or plug element can be provided at the isolationdevice, for example at the support frame to connect the isolation deviceto an external electrical energy device for supplying said lightsources.

According to a further preferred embodiment, the isolation deviceaccording to the invention further comprises an opening in said firstinflatable bag and a flexible hose defining an interior space, whereinsaid flexible hose is attached to said first inflatable bag along thecircumference of said opening, said flexible hose being adapted to takeup a device like a surgical instrument in its interior space and saidflexible hose is made from a flexible material adapted to be wrappedaround a longitudinal axis of said hose to establish a sealing in awrapped region such as to seal a sterile interior space of saidinflatable bag, wherein an inner transport space in said flexible hose,which is sealed such a wrapped region, can be moved from outside of saidfirst inflatable bag into said sterile interior space of said firstinflatable bag. According to this embodiment, a specific insertion unitis provided at said first inflatable bag allowing to introduceinstruments or any other devices from outside the inflatable bag intothe sterilized interior space inside said inflatable bag. Further, suchunit can be used in a reverse direction to transfer material out of saidsterilized interior space to the outside of the inflatable bag. Thespecific functionality of this insertion or discharging/exporting unitis a flexible hose attached to an opening in the first inflatable bagand generally sealing said opening in that the flexible hose is wrappedalong its longitudinal axis to define a wrap sealing region. By this,the opening is kept closed in a usual condition, wherein no componentsare to be inserted or to be exported into/out of the sterilized interiorspace. However, in use, the components may be put into the hose and thehose may be wrapped to enclose the component and hereafter atransitional, longitudinal movement of the wrapped component through theopening together with the wrapped section of the hose may be performedsuch as to move the component from inside to outside or from outside toinside, respectively. Hereafter, the wrapping of the hose may bedewrapped such as to release the component out of the hose in case ofinserting an instrument into the interior space. Further, the sealingprovided by said wrap may be maintained, for example if any organicwaste or the like is to be exported and kept sealed. Further thewrapping might be accomplished alternatively with two circumferentialsealing clips to define one sealing region and allow cutting between theclips, thus sectioning and preventing an unwanted subsequent unwrapping.The advantage would be the individual and independent wrapping ofcomponents and their handling. A further sealing method would beaccomplished with intermitted distanced adhesive tape sections in theinner part of the hose, which also would provide a tight sealing toblister packed items or inside the hose. Sterile access to the componentwould be possible by a controlled opening of such sealing clips or tapesealings which then may also effect opening of the adherent blisterpackage or medication containers.

According to a further preferred embodiment, the first inflatable bagmay comprise an opening, said opening being closed by a lock adapted tochannel a container for surgical instrument into said first inflatablebag. Such a lock may be designed in different ways. In particular, thelock may comprise two rollers biased in close contact to each other andthe container may be pushed through the two rollers and at the same timethe rollers may be adapted to disconnect and wrap a foil covering thetop side of the container such as to maintain a sterile environmentinside the container and opening the container upon insertion of thecontainer through the lock into the interior sterilized space inside thebag. Alternatively any instrument trays inside the container may befully enclosed by a steam permeable bag which has a removable lid, whichis fitting to the lock. Thus only the inner part of the container may bepushed through the rollers whereas the container itself remains outsideof the sterile space.

According to a further preferred embodiment the first inflatable bag maycomprise a lower frame coupling element for coupling the firstinflatable bag with a device for producing and maintaining a sterilesurface on a patient's skin as explained beforehand, in particular withthe first frame element or with the second frame element of the saiddevice. By this, the isolation device can be perfectly used inconnection with the convenient device for producing the sterile surfaceon the patient's skin. In particular, such a device can be part of theinflatable bag such that the first frame or the second frame is attachedto the inflatable bag and thus, upon attaching the first frame to thepatient's skin, a sterile interior space inside the inflatable bag canbe opened to the patient's skin after it has been sterilized by theflooding action with the sterilizing agent as described beforehand.

Still further, it is to be understood that inside the isolation devicean assisting device for facilitating the taking on and taking off of asurgical glove can be arranged. In particular, a plurality of suchassisting devices including a surgical glove can be arranged inside theinflatable bag such as to allow a surgeon to take on such surgicalgloves when reaching through the access ports into the inflatable bag.

According to a further aspect of the invention it is provided a devicefor introducing sterile instruments into an operation chamber or aninstrument chamber, comprising an introduction frame; a first roller anda second roller arranged rotatable around their respective longitudinalaxis, and attached to said introduction frame, such that thelongitudinal axis of the first roller and the longitudinal axis of thesecond roller are parallel, wherein the first roller and the secondroller are further attached to said introduction frame such as to bemovable along an axis extending perpendicular to their respectivelongitudinal axis; wherein a distance between the first roller and thesecond roller is determined by a position of a movement of the first andsecond roller along the axis extending perpendicular to the longitudinalaxes, and wherein said first and second rollers are biased versus eachother to contact each other and said first and second roller can bemoved along said axis to increase said distance to allow insertion of aninstrument through a gap provided by said distance.

According to this aspect of the invention, an improved device forintroducing sterile instruments into an operation chamber or aninstrument chamber is provided. The device comprises a first and asecond roller which in a non-use condition sealingly engage with eachother in that the two rollers are biased against each other. The tworollers are rotatably arranged in a frame and can conduct a rotationalmovement against said frame. At least one of the two rollers can furtherbe moved against said frame in a direction perpendicular to itsrotational axis such as to establish a gap to the other roller. Thismovement can be a linear sliding movement or a movement along a curve orthe like. According to the invention, by such a movement of one of therollers or the both rollers will provide a gap between the rollers andan instrument may be inserted through such gap. The instrument maypreferably be in a blister package of two flexible foils and in suchcase, the rollers are adapted to take up these foils in such a way thatthe upper roller takes up the upper foil and the lower roller takes upthe lower foil. As an example for such specific embodiment, alongitudinal slit may be provided inside the rollers and an edge endregion of the upper and the lower foil may be inserted into the slit ofthe upper roller and the lower roller, respectively. In such case, ifthe instrument is inserted by establishing a small gap between therollers and pushing the blister package with the instrument through saidbag by a rolling action of the rollers, the blister package is torn openand the instrument is pushed through the two rollers. By this, a sterileenvironment on the one side of the two rollers can be maintained whereason the other side of the rollers a non-sterile environment may bepresent.

The so defined device is particularly well suited for being connected toa flexible bag of an isolation device as described beforehand so as toallow insertion of instruments into the interior sterilized space insidesuch inflatable bag.

According to a preferred embodiment of this aspect of the invention,said first roller is adapted to wrap up an upper foil of a sterileblister packaging of said instrument and said second roller is adaptedto wrap up a bottom foil of the sterile blister packaging upon insertionof said instrument through said gap in the blister packaging.

According to a further preferred embodiment, the device may be furtherimproved by a box for receiving the instrument inside the operationchamber or the instrument chamber. Such a box or container may preventan instrument being inserted into an inflatable bag to get lost or tofall onto the patient's skin or the like.

It is particularly preferred that said introduction frame is attached toa first or second inflatable bag of an isolation device as describedbeforehand.

According to a further aspect of the invention, it is provided amechanical cabinet for storing of instruments inside an operationchamber or an instrument chamber, comprising: a shelf frame; a storagearea and an extraction area; and at least one shelf movably, inparticular pivotably affixed to the shelf frame, such as to be moved orpivoted, respectively from the storage area into the extraction area andfrom the extraction area into the storage area.

The so defined mechanical cabinet is particularly suited for storing aplurality of instruments or devices for conducting a surgical operationin a quite limited space like for example inside an inflatable bagdefining a confined and limited sterilized volume above a skin region ofa patient. A specific problem related to operating procedures conductedin such an environment is the limited space defined by such aninflatable bag and the need to preferably provide all instrumentsrequired for conducting the surgical operation inside said inflatablebag. In such a situation, it is preferable to arrange a mechanicalcabinet inside the inflatable bag and to store and present theinstruments and any further devices required for the operation on theshelves of the mechanical cabinet. The surgeon or assistant personal maythen conveniently move one shelf or a plurality of shelves relative tothe shelf frame to allow easy access to the instruments positioned onthe shelves.

According to a preferred embodiment, at least one shelf rigidly affixedto the shelf frame, the at least one rigidly affixed shelf being spacedfrom the at least one movably affixed shelf by a predefined distance.According to this embodiment, one rigid shelf will help defining astable standing of the mechanical cabinet and one movable shelf willallow to significantly increase the storage capacity of the mechanicalcabinet and allow simple access to the instruments.

Still further, it is preferred that the mechanical cabinet furthercomprises at least one, preferably two vertically disposed andsynchronously driven endless chains, wherein the at least one shelf isaffixed in a substantially horizontal orientation of an upper surface ofsaid shelf to the endless chain(s). According to this embodiment, theshelves are arranged in a horizontal extension such that the instrumentsand devices can be positioned onto the shelves and kept thereon bygravity force and the shelves can be moved in such a way as to maintainits horizontal orientation. In this embodiment, the shelves are arrangedand moved like the cabins in a paternoster lift design and thussignificantly improve the capacity for storing instruments inside alimited space by at the same time allowing simplified and quick accessto the instruments.

According to an alternative embodiment, the at least one pivotablyaffixed shelf is mounted to said vertically arranged shaft or axis for apivotal movement around said shaft or axis, respectively; and whereinthe at least one pivotably mounted shelf comprises holding means forreleasably holding of the instruments on said shelf. In this embodiment,the shelves are arranged in a vertically extended arrangement such as todefine vertically extending surfaces for positioning the instruments anddevices thereon. It is to be understood that in such case theinstruments cannot be positioned and fixed on the shelves by gravityforce but rather specific holding means must be provided on the shelvesfor releasably holding the instruments on the shelves. In thisparticular embodiment the shelves are arranged like the pages of a bookstanding upright on a surface and the shelves can be moved around avertical axis in the same way as the pages of an upright book can bescrolled or skimmed through.

According to this preferred embodiment it is further preferred that saidholding means are selected from: (a) magnetic means incorporated intosaid shelf, (b) hooks attached to said shelf, (c) openings in saidshelf. According to this further preferred embodiment, specific meansare provided on said shelves to fix the instruments or devices on theshelf, wherein it is understood that preferably all three differentmeans for fixing the instruments or devices on the shelves are providedon each shelf to allow a variability with regard to differentinstruments and devices.

According to a further preferred embodiment, the mechanical cabinet canbe further improved by a plurality of movable shelves to improve andincrease the capacity for storing instruments and devices.

Still further, it is to be understood that the isolation devicedescribed beforehand may be further improved by arranging a mechanicalcabinet as described beforehand inside the first or the secondinflatable bag. This will allow to provide and offer a large number ofinstruments and devices to a surgeon conducting a surgical operationusing such an isolation device.

Still further, an aspect of the invention is the use of such amechanical cabinet as described beforehand in an operation or aninstrument chamber, in particular in an instrument chamber as describedbeforehand.

As regards the advantages, embodiment variants, and embodiment detailsof the method according to the present disclosure and its possiblefurther developments, reference is made to the description providedherein of the respective features, as will be understood and appreciatedby those skilled in the art upon studying the following specification,claims, and appended drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

Preferred embodiments of the invention are described with reference tothe enclosed figures. In the figures:

FIG. 1 is a perspective view of a sterilizing device according to anembodiment of the invention;

FIG. 2 is a cross-sectional view of the sterilizing device according toFIG. 1;

FIG. 2a shows a detailed view of FIG. 2;

FIG. 3 is a schematic cross-sectional view of an isolation deviceaccording to an embodiment of the invention;

FIG. 4a is a perspective view of a first configuration of an assistingdevice according to an embodiment of the invention;

FIG. 4b is the embodiment according to FIG. 4a in a secondconfiguration;

FIG. 5a is a schematic cross-sectional view of the assisting device inthe first configuration according to FIG. 4 a;

FIG. 5b is a view according to FIG. 5a in a second configurationaccording to FIG. 4 b;

FIG. 6a is a perspective view of an assisting device according to asecond embodiment of the invention in a first configuration;

FIG. 6b is the embodiment according to FIG. 6a in a secondconfiguration;

FIG. 7a is a cross-sectional view of the embodiment according to FIGS.6a, 6b in a first configuration;

FIG. 7b is the embodiment of FIG. 7a in a second configuration;

FIG. 8 is an introducing device according to a preferred embodiment ofthe invention in a schematic side view;

FIG. 9 is an introducing device in a schematic, side-sectional viewaccording to one preferred embodiment of the invention;

FIG. 10 according to a first preferred embodiment of the invention in aschematic perspective view;

FIG. 11 is a mechanical cabinet according to a second preferredembodiment of the invention in a schematic side view;

FIG. 12a is a schematic perspective view of a second preferredembodiment of a framework for an isolation device according to FIG. 3;

FIG. 12b is another perspective view of the embodiment of FIG. 12 a;

FIG. 13a is a schematic perspective view a third preferred embodiment ofa framework for an isolation device according to FIG. 3;

FIG. 13b is another perspective view of the embodiment of FIG. 13 a;

FIG. 14 is a perspective schematical view of an isolation device in usefor a spine surgery;

FIG. 15a is a perspective view of a third preferred embodiment of amechanical cabinet;

FIG. 15b is another perspective view of the embodiment of FIG. 15a ; and

FIGS. 16a, 16b are two perspective schematic views of a furtherpreferred embodiment of an isolation device in use for a lateral spinesurgery.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

As referenced in the Figures, the same reference numerals may be usedherein to refer to the same parameters and components or their similarmodifications and alternatives. For purposes of description herein, theterms “upper,” “lower,” “right,” “left,” “rear,” “front,” “vertical,”“horizontal,” and derivatives thereof shall relate to the presentdisclosure as oriented in FIG. 1. However, it is to be understood thatthe present disclosure may assume various alternative orientations andstep sequences, except where expressly specified to the contrary. It isalso to be understood that the specific devices and processesillustrated in the attached drawings, and described in the followingspecification, are simply exemplary embodiments of the inventiveconcepts defined in the appended claims. Hence, specific dimensions andother physical characteristics relating to the embodiments disclosedherein are not to be considered as limiting, unless the claims expresslystate otherwise. The drawings referenced herein are schematic andassociated views thereof are not necessarily drawn to scale. Identicalelements or elements with essentially the same or similar function arereferred to with the same reference number in the figures.

Referring first to FIGS. 1, 2, and 2 a, a device for producing andmaintaining a sterilized surface on a skin of a patient is shown inthese figures in a preferred embodiment of the invention. The devicecomprises a first frame 10 of rectangular shape being composed of fourlinear frame members 11 a-d which are joined to each other at thecorners of the frame. The frame members 11 a-d of the first framegenerally have an L-shaped cross-section and are arranged in such a waythat one leg of the L-shaped cross-section lies in a horizontal plane 1.Generally, the first frame 10 maybe composed of different profiled framemembers, e.g., a U-shaped cross-section or a rectangular cross-sectionmaybe used to form the first frame, as well.

The first frame defines a lower adhesion surface 12 in the horizontalplane 1 which can be attached to the patient's skin. The frame memberssurround an inner opening 20 of rectangular shape which is the openingserving the surging to conduct the surgical operation.

A first foil 30 is provided at the first frame 10 and covers the wholeinner opening 30 being attached or coupled to the frame members 11 a-dof the first frame on all four sides. As can be seen in FIG. 2a , thefirst foil 30 reaches through a slit 13 in one frame member 11 a and ahandle 31 preferably including an opening 32, is provided on the side ofthe first foil 30 protruding sideways out of the first frame. The handle31 allows a user to pull out the first foil 30 out of the first frameafter a sterilizing procedure has been accomplished.

In at least one region, the first foil 30 is in a short distance to thelower adhesion surface 12 of the first frame to the skin. In otherregions, the first foil 30 may lay in the plane of the adhesion surface.Thus, a small sterilizing space is defined between the first foil 30 andthe skin of the patient if the first frame is attached to the skin andthe first frame.

A first channel 40 with a first connector 41 is arranged in the framemember 11 b of the first frame and reaches through the frame member. Thefirst connector 41 has an outer connector dimension of circularcross-section allowing to adapt a standardized connector to the firstconduit like a luer lock or the like. The first channel 40 opens intothe space established between the first foil 30 and the skin of thepatient with an elongated cross-section, such as to be adapted incross-section to the small distance between the first foil and the skinof the patient.

A second fluid channel 50 with connector 51 is provided in frame member11 d in the opposite corner region to the first channel 40. The secondchannel 50 is designed in a similar manner as the first channel 40 andconnector 41. Whereas the first channel 40 serves to insert asterilizing agent from outside the frame into the space between thefirst foil 30 and the skin of the patient, the second channel 50 servesto remove such sterilizing agent after a certain activating time when acomplete sterilization of the skin of the patient and of the bottomsurface of the first foil 30 has been reached.

A second frame 60 is provided and composed of four L-shaped framemembers 61 a-d. The second frame 60 has a slightly smaller dimensionthan the first fame 10 such as to allow the second frame 60 to beinserted into the first fame 10. As can be seen in detail in FIG. 2a ,the second frame 60 is in sliding and sealing contact to the inner wallsurface of the upright L-shaped lack member of the first frame members.A second foil 70 is spanned across the opening in parallel arrangementto the first foil 30 and attached to the lower end of the second frame60. Thus, after the sterilizing process has been accomplished and thefirst foil 30 has been removed by pulling the handle 31, the secondframe 60 can be pushed downwards to bring the second foil 70 in contactwith the skin. The second foil 70 has a lower adhesive surface 71 toadhere and firmly attach to the skin of the patient thus establishing aprotective cover on the skin in the region of the surgery and theincision. An edge region 71 a is adapted to establish a strongerattachment to the patient's skin than the rest of the adhesive surface71.

Generally, it is to be understood that both the first frame 10 and thesecond frame 60 can be collapsed in such a way that the legs of theL-shaped profiles of the frame members can be brought from therectangular arrangement to each other to a parallel arrangement to eachother wherein the legs lie directly onto each other.

The sterilizing device shown in FIGS. 1, 2, and 2 a is generallywell-suited to be used as an independent device for conducting a safeand quick sterilizing action of a skin region of a patient prior to asurgical operation. In particular, the sterilizing device can be used inconnection with an inflatable bag defining a limited sterilized spaceabove, such a skin region. For this purpose, such an inflatable bag maybe attached to the first frame 10 or the second frame 60 in a sealingengagement and may in particular be clamped and firmly attached to thefirst and/or second frame 10, 60 by adhesive effects after the firstframe 10 and second frame 60 has been collapsed.

FIG. 3 shows a sterilizing device comprising such an inflatable bag 100according to a preferred embodiment of the invention. As can be seen, asterilizing device comprising first and second frames 10, 60 accordingto FIG. 1 can be attached to the bottom cross-section of the inflatablebag as schematically shown in FIG. 3.

The device shown in FIG. 3 generally comprises an inflatable bag 100which may have a dome-shaped geometry, as shown in the figure but mayalternatively have different other geometries. The inflatable bag 100 iscoupled to two separate frame work members 110, 120 which define andmaintain a specific geometry of the inflatable bag 100 independentlyfrom a specific pressure condition inside of the inflatable bag 100.Illuminating devices 111, 112, 121, 122 are arranged at the frameworkmembers 110, 120 to illuminate the inner space inside the inflatable bag100.

An upper window region 101 is made of a fully crystal clear transparentmaterial to allow precise observation of any handling processes insidethe inflatable bag 100.

The inflatable bag 100 further comprises access ports 105, 106 in theinflatable bag 100. The access ports 105, 106 are combined with sleevesand gloves to define a sealed interior space, but allows a surgeon orassisting personnel to reach into the inner space from outside theinflatable bag 100.

Still further, an introducing and exporting device 130 is provided inthe inflatable bag 100 at the lower bottom region. This introducing andexporting device comprises two rotatable rollers 131, 132 which can bemoved apart from each other to open a gap between the rollers 131, 132allowing the surgeon or assisting personnel to introduce instruments orthe like from outside into the interior space. This introducing andimporting device 130 is specifically adapted to conduct such aninsertion or exporting action without affecting the sterile environmentinside the inflatable bag 100 even if a non-sterile environment ispresent outside the inflatable bag 100. The insertion and exportingdevice 130 is explained in further detail hereafter with reference toFIG. 8.

In a first configuration, FIG. 4a shows an assisting device 200 fortaking off and putting on a surgical glove. The assisting device 200 isshaped like a pouch and has a flattened configuration, as shown in FIGS.4a and 5a . As can be seen, a surgical glove 250 can be inserted intothe interior 210 of a fluid-tight wall defining the pouch-like geometryof the assisting device 200. The surgical glove 250 is reversed in itscuff region 251 and thus engaged sealingly with the edge 211 of anopening 220 on one side of the pouch. Generally, alternatively to thisreversing and thus sealingly engaging of the cuff region 251 of thesurgical glove 250, other mechanisms may be used to sealingly engage thecuff region 251 of the glove to the fluid-tight wall 200 in the edgeregion 211 of the opening 220.

The fluid-tight wall 200 may be deformed from the flattenedconfiguration with an approximately elliptical cross-sectional shape, asshown in FIGS. 4a, 5a , to an enlarged shape with a cylindricalcross-section, as shown in FIGS. 4b, 5b . In this enlarged secondconfiguration the inner space 210 of the fluid-tight wall issignificantly increased compared to the size of the inner space in thefirst configuration shown in FIGS. 4a, 5a . Thus, in a space region 210a, which is sealingly enclosed by the fluid-tight wall and the surgicalglove 250, a low pressure is established and since on the other side,namely inside the glove 210 b, atmospheric pressure is present, thiseffects a stretching and enlarging of the surgical glove 250 in thesecond configuration. The enlarged dimension of the surgical glove 250in the second configuration can be seen in FIG. 5b . As will beunderstood, a person intending to put on the surgical glove 250 may noweasily slide his hand into the surgical glove 250 and may thereafterreturn the assisting device into the first configuration, therebytightly attaching the surgical glove 250 to his hand and thereafterremove his hand from the assisting device. In the same way, a person maywith the surgical glove 250 on his hand may slide his hand into theassisting device in the first configuration, establish a sealing contactto the edges of the first opening, e.g., by reversing the surgical glove250 in the cuff region 251 as shown in the figures, or in any otherways, and thereafter deform the fluid-tight wall into the secondconfiguration to thereby enlarge the surgical glove 250 and pull thesurgical glove 250 away from the hand to remove the hand from thesurgical glove 250 and the assisting device in said secondconfiguration. This easily allows removing the surgical glove 250 from ahand without the need of contacting any contaminated surfaces of thesurgical glove 250.

FIGS. 6a, 6b, 7a, and 7b , show a second preferred embodiment of anassisting device for putting on and removing the surgical glove 250. Thedevice comprises a first, tube-like component 310 and a second, cup-likecomponent 320 which is inserted into the first component 310. Bothcomponents 310, 320 have a similar cross-sectional geometry whereas thefirst component 310 is dimensioned slightly larger than the secondcomponent 320. The first component 310 is open at both ends and definesan opening 330 at one side of the device. The second component 320 isopen at one end only and is arranged such as to be open towards theopening 330 on one side of the device as well but is closed by a bottomlid 321 on the other side. The second component 320 sealingly engagesthe first component 310 by a circumferential sealing lid 322 arranged atthe front end region of the second component 320 close to the opening ofthe second component 320. As can be seen in FIGS. 6a, 6b and 7a, 7b ,the second component 320 can be moved in a sliding movement in an axialdirection in relation to the first component 310.

A surgical glove 350 can be attached sealingly to the opening 330 of thefirst component 310 and may reach into an interior space 340 defined bythe first and second components 310, 320. By this, the interior space340 is divided into a completely sealed region 340 a against theatmosphere by the first and the second components 310, 320 and thesurgical glove 350 and a region 340 b inside the surgical glove 350.FIGS. 6a, 7a show the assisting device in a first configuration whereinthe inner space 340 has a first volume size. As can be seen in FIGS. 6b,7b , when sliding the second component 320, such as to elongate thetotal length of the assisting device, the inner space 340 issignificantly increased by the telescoping movement of the first and thesecond components 310, 320 relative to each other. By this, a vacuum isestablished in the space region 340 a effecting a significantenlargement of the surgical glove 350 being under atmospheric pressurein the space region 340 b. By this, the surgical glove 350 issignificantly increased and thus maybe put on or removed conveniently bya user.

FIG. 8 shows a device for inserting and exporting articles, likeinstruments or medical devices, from a first, non-sterile environment501 into a second, sterile environment 502, and vice versa. The deviceis particularly adapted to be incorporated into an isolation device asdescribed beforehand.

As can be seen, the device comprises a frame 510 having a flange 511which can be mounted to the inflatable bag 100 in a sealing arrangement.In the frame 510, two rollers 520, 530 are mounted rotatably along itslongitudinal axis. The rollers 520, 530 are shown in a closed conditionof the device and in this condition the rollers 520, 530 are in contactto each other and in contact to the frame 510 to completely seal anopening 540. In this closed condition, the rollers 520, 530 are biasedversus each other by a spring 550.

The axis or shafts of the rollers 520, 530 are positioned in a curvedgroove or curved opening 521, 531, respectively. The curvedgrooved/openings 522, 532 allow the two rollers 520, 530 to slide alonga curved travel path wherein the two rollers 520, 530 are pushed awayfrom each other, thus giving an insertion/exporting opening between thetwo rollers 520, 530. As can be seen in dashed lines when being pushedtowards the end the travel path, the two rollers 520, 530 give way foran instrument or a device having the size of the opening 540 as amaximum dimension.

By this, an instrument or device may be pushed from the left side inFIG. 8 to the abutting region of the two rollers 520, 530, thus pushingthe two rollers 520, 530 away from each other and allowing the insertionof the device/instrument from the left side to the right side. Theinstrument may thereafter be taken up in a container 560 on the rightside.

The device shown in FIG. 8, in particular, allows a sterile incursion ofinstruments from a non-sterile environment on the left side of thedevice to a sterile environment on the right side of the device. This isconducted by instruments or devices being contained in a blisterpackage. Both rollers comprise a slit 521, 531 wherein the end edgeregions of such two foils defining such a blister package can beinserted. When pushing such instrument in such blister package throughthe gap between the two rollers 520, 530, the blister package is tornopen and the two foils defining the blister package are wrapped aroundthe rollers 520, 530. By this, the instrument is released out theblister package into the environment 502 but at the same time the gapbetween the two rollers 520, 530, which is open for the time of theinsertion, is kept sealed against environment 501 by the blister packagebeing wrapped around the two rollers 520, 530.

As can be seen, the two rollers 520, 530 are pushed or drawn back intothe closed position by the spring 550 after such an insertion procedure.

FIG. 9 shows a device for inserting or exporting objects into or out ofa controlled environment, such as a sterile environment, by a simplemechanical set up. A frame 610 defines an opening 620, e.g., a circularopening. The frame 610 may be attached to an inflatable bag 100 or thelike which separates a controlled atmosphere, such as a sterileenvironment, against the outside.

A flexible hose 630 is attached to the frame and has a certain length.The flexible hose 630 may extend to one side with a first portion 631,may then be reversed to be directed to an opposite direction with asecond portion 632 and have a wrapped portion 633, wherein the flexiblehose 630 is wrapped around its own to define a sealing. In a portion634, an object 640, e.g., infectious waste or the like, may bepositioned and may be sealed on both sides by such wrappings in hoseregions 633, 635. A remaining length portion 636 of the flexible hose630 may be used to further seal such objects with additional wrapregions. By this, the flexible hose 630 may be used to seal multiplesuch objects and to allow transfer of such objects from the inside tothe outside, or vice versa, by moving the flexible hose 630 through theopening 620.

FIG. 10 shows a mechanical cabinet for storing instruments thereon. Themechanical cabinet generally comprises a vertical axis 710, which ismounted on a base plate 720 for standing upright in a stable position.Three sheets 731, 732, 733 are mounted to the axis 710 in a rotatablemanner such as to rotate around the vertical axis 710. By this, thesheets 731, 732, 733 can be rotated so as to allow a user to access anyinstruments clipped or hooked to any of the sheets 731, 732, 733 in asimple way. Generally, the vertical axis 710 may be a shaft, and thesheets 731, 732, 733 may be mounted rigidly to the shaft wherein theshaft itself is mounted rotatably in a bearing 711 on the bottom side.Alternatively, the vertical axis 710 may be an axle, and the sheets 731,732, 733 may be mounted to said axle in a rotatable manner via bearingsor the like (not shown). It is to be understood that one of the sheetsmay be mounted rigidly to the base plate to increase stability of thewhole construction whereas the other sheets may be mounted rotatably.Further, it is to be understood that instead of having three sheetsthere may be only two sheets, or four sheets, or even more than foursheets.

FIG. 11 shows a further preferred embodiment of a mechanical cabinet forstoring multiple instruments and devices in a limited space. The devicecomprises a number of six sheets 810 af, but other numbers of sheets,such as three, four, five, seven, eight, or even more, may be provided.The sheets 810 a-f are mounted to a moving mechanism, e.g., a frame,having a curved groove or opening or a lever mechanism allowing to movethe sheets 810 a-f along a curved path 830 in a closed loop. Generally,the sheets 810 a-f are positioned inside the frame in such a way thatthey always keep a horizontal orientation and which may be achieved by aswinging mounting of the sheets 810 a-f inside the device and keepingthe orientation by gravity, or it may be achieved by lever mechanismswherein two levers are defining the motion of each sheet and thusmaintain such horizontal orientation by a parallelogram arrangement orthe like.

The sheets 810 a-f are adapted to receive instruments, devices, or thelike on the top surface, and allow a user to simply access suchinstruments by moving the sheets 810 a-f into a position wherein thoseinstruments required by the user are accessible from the respectivesheet. It is to be understood that the sheets 810 a-f may be movableindependently from each other or may be interconnected to each othersuch that a synchronous movement of the sheets is possible.

The moving mechanism, like the frame defining the travel path of thesheets, is mounted to a base plate 820 for a safe and secure standing ofthe mechanical cabinet.

Generally, the mechanical cabinet shown in FIGS. 10 and 11 is perfectlysuited for being used inside an inflatable bag, in particular ininflatable bag of an instrument chamber for conducting a surgicaloperation.

FIGS. 12a, 12b show a second preferred embodiment of a framework for anisolation device according to FIG. 3 having four, bow-shaped framemembers in a twofold symmetrical arrangement.

FIGS. 13a, 13b show a third preferred embodiment of a framework for anisolation device according to FIG. 3 having two curved frame members ina symmetrical arrangement and being open towards one side.

FIG. 14 shows an isolation device with the inflatable bag 100 left awayfor better understanding in application for a spine surgery.

FIGS. 15a, 15b show a second preferred embodiment of a mechanicalcabinet according to a paternoster arrangement.

FIGS. 16a, 16b show a further preferred embodiment of an isolationdevice in use for a lateral spine surgery with the patient lying on hisside. As can be seen, in this embodiment the frame of the isolationdevice is not supported on the skin of the patient but is rathersupported onto the operation table. Preferably, the frame is arrangedmainly or completely outside of the inflatable bag, i.e., it is notarranged in the inner sterile space defined by said inflatable bag.

It will be understood by one having ordinary skill in the art thatconstruction of the described present disclosure and other components isnot limited to any specific material. Other exemplary embodiments of thedisclosure disclosed herein may be formed from a wide variety ofmaterials, unless described otherwise herein.

For purposes of this disclosure, the term “operably coupled” (in all ofits forms, couple, coupling, coupled, etc.) generally means the joiningof two components (electrical or mechanical) directly or indirectly toone another. Such joining may be stationary in nature or movable innature. Such joining may be achieved with the two components (electricalor mechanical) and any additional intermediate members being integrallyformed as a single unitary body with one another or with the twocomponents. Such joining may be permanent in nature or may be removableor releasable in nature unless otherwise stated.

For purposes of this disclosure, the term “operably connected” (in allof its forms, connect, connecting, connected, etc.) generally means thatone component functions with respect to another component, even if thereare other components located between the first and second component, andthe term “operable” defines a functional relationship betweencomponents.

It is also important to note that the construction and arrangement ofthe elements of the present disclosure as shown in the exemplaryembodiments is illustrative only. Although only a few embodiments of thepresent innovations have been described in detail in this disclosure,those skilled in the art who review this disclosure will readilyappreciate that many modifications are possible, e.g., variations insizes, dimensions, structures, shapes and proportions of the variouselements, values of parameters, mounting arrangements, use of materials,colors, orientations, etc. without materially departing from the novelteachings and advantages of the subject matter recited. For example,elements shown as integrally formed may be constructed of multiple partsor elements shown in multiple parts may be integrally formed, theoperation of the interfaces may be reversed or otherwise varied, thelength or width of the structures and/or members or connector or otherelements of the system may be varied, the nature or number of adjustmentpositions provided between the elements may be varied. It should benoted that the elements and/or assemblies of the system may beconstructed from any of the wide variety of materials that providesufficient strength or durability, in any of the wide variety of colors,textures, and combinations. Accordingly, all such modifications areintended to be included within the scope of the present innovations.Other substitutions, modifications, changes, and omissions may be madein the design, operating conditions, and arrangement of the desired andother exemplary embodiments without departing from the spirit of thepresent innovations.

It will be understood that any described processes or steps withindescribed processes may be combined with other disclosed processes orsteps to form structures within the scope of the present disclosure. Theexemplary structures and processes disclosed herein are for illustrativepurposes and are not to be construed as limiting.

It is to be understood that variations and modifications can be made onthe aforementioned structure and method without departing from theconcepts of the present disclosure, and further it is to be understoodthat such concepts are intended to be covered by the following claimsunless these claims by their language expressly state otherwise.

1. A device for introducing sterile instruments into an operationchamber or an instrument chamber comprising: an introduction frame; anda first roller and a second roller arranged rotatable around theirrespective longitudinal axis, and attached to the introduction frame,wherein the longitudinal axis of the first roller and the longitudinalaxis of the second roller are parallel, and the first roller and thesecond roller are attached to the introduction frame so as to be movablealong an axis extending perpendicular to their respective longitudinalaxis; wherein a distance between the first roller and the second rolleris defined by a position of a movement of the first and second rolleralong the axis extending perpendicular to their longitudinal axes; andwherein the first and second rollers are biased to contact each otherand the first and second roller are moveable along the axis extendingperpendicular to their longitudinal axes to increase the distance toallow insertion of an instrument through a gap defined by the distance.2. The device according to claim 1, wherein the first roller is adaptedto wrap up an upper foil of a sterile blister packaging of theinstrument and the second roller is adapted to wrap up a bottom foil ofthe sterile blister packaging upon insertion of the instrument throughthe gap.
 3. The device according to claim 1, further comprising a boxfor receiving the instrument inside the operation chamber or theinstrument chamber.
 4. The device according to claim 1, wherein theintroduction frame is attached to a first inflatable bag of an isolationdevice for providing a sterile operation chamber above a skin region ofa patient, the isolation device comprising: the first inflatable bagdelimiting the sterile operation chamber against the ambientenvironment, the first inflatable bag comprising a first and a secondaccess opening to allow a user to insert a first arm and a second arminto the operation chamber, and wherein the first inflatable bag iscoupled to a support frame having a transport configuration and anoperation configuration, wherein while in the transport configuration,the first inflatable bag is confined so as to have compact dimensions,and while in the operation configuration, the first inflatable bag isextended to form the sterile operation chamber; a chamber operationopening to allow access to the skin region of the patient; and a windowfor observing handling operations inside the sterile operation chamber.5. The device according to claim 4, wherein the support frame compriseshollow support frame members having at least one connector forintroducing a fluid into the support frame members, and wherein while inthe transport configuration, the support frame members are deflated andslack, and while in the operation configuration, the support framemembers are inflated to a pressurized state such that the supportmembers are rigid.
 6. The device according to claim 4, wherein thesupport frame comprises hollow support frame members having at least oneconnector for introducing a fluid into the support frame members, andwherein while in the transport configuration, the support frame membersare deflated and slack, and while in the operation configuration, acurable liquid is inserted into the support frame member, and thecurable liquid is cured to a hardened condition.
 7. The device accordingto claim 4, wherein the support frame is formed by a plurality ofelastically joined rigid support frame elements.
 8. The device accordingto claim 4, wherein, while in the operation configuration, the supportframe elements comprise: a middle support frame element supporting theinflatable bag in a middle section between the first and second accessopening; a bottom support frame element arranged below the first andsecond access opening; and a top support frame element arranged abovethe first and second access opening.
 9. The device according to 4,further comprising an instrument chamber separate from the operationchamber and enclosed by a second inflatable bag coupled to a secondarysupport frame, wherein a transfer port is provided between the operationchamber and the instrument chamber.
 10. The device according to claim 9,wherein: the first inflatable bag comprises an operation chamberconnection frame encompassing an operation chamber transfer opening; thesecondary inflatable bag comprises an instrument chamber connectionframe encompassing an instrument chamber transfer opening; an operationchamber shutter foil attached to the operation chamber connection frameto provide a fluid-tight sealing of the operation chamber transferopening; and an instrument chamber shutter foil attached to theinstrument chamber connection frame to provide an fluid-tight sealing ofthe instrument chamber transfer opening.
 11. The device according toclaim 10, wherein: the operation chamber connection frame comprises anoperation chamber connection surface facing the instrument chamberconnection frame; the instrument chamber connection frame comprises aninstrument chamber connection surface facing the operation chamberconnection frame; the operation chamber shutter foil comprises aoperation chamber shutter protrusion; and the instrument chamber shutterfoil comprises an instrument chamber shutter protrusion; wherein whenthe operation chamber connection surface and the instrument chamberconnection surface are brought into fluid-tight contact and theoperation chamber shutter foil and the instrument chamber shutter foilare removed by means of the operation chamber shutter protrusion and theinstrument chamber shutter protrusion, respectively, the operationchamber transfer opening and the instrument chamber transfer openingforming the transfer port between the operation chamber and theinstrument chamber.
 12. The device according to claim 11, wherein: theoperation chamber connection frame comprises at least one connectionprotrusion extending from the operation chamber connection surface alonga direction substantially perpendicular to a plane defined by theoperation chamber connection frame; and wherein the instrument chamberconnection frame comprises at least one connection groove adapted toreceive the at least one connection protrusion.
 13. The device accordingto claim 4, wherein a plurality of light sources is arranged at thesupport frame.
 14. The device according to claim 13, wherein theplurality of light sources is partially integrated into the supportframe.
 15. The device according to claim 4, further comprising anopening in the first inflatable bag and a flexible hose defining aninterior space, wherein the flexible hose is attached to the firstinflatable bag along the circumference of the opening, the flexible hoseis adapted to take up a device in its interior space, and the flexiblehose is made from a flexible material adapted to be wrapped around alongitudinal axis of the flexible hose to establish a seal in a wrappedregion to seal a sterile interior space of the first inflatable bag, andwherein an inner transport space in the flexible hose sealed within thewrapped region can be moved from outside of the first inflatable baginto the sterile interior space of the first inflatable bag.
 16. Thedevice according to claim 4, further comprising an opening in the firstinflatable bag, the opening being closed by a lock adapted to channel acontainer for surgical instruments into the first inflatable bag. 17.The device according to claim 4, wherein the window is adapted forcoupling an imaging device to the window by an adaptor ring attached tothe first inflatable bag or wherein an additional window for coupling animaging device to the window by an adaptor ring attached to the firstinflatable bag is provided.
 18. The device according to claim 17, wherethe imaging device is an optical system or a microscope.
 19. The deviceaccording to claim 4, wherein a lower frame coupling element is attachedto the first inflatable bag for coupling the first inflatable bag with adevice for producing and maintaining a sterile surface on a patient'sskin comprising: a first frame having first frame elements encompassinga first inner operation opening allowing access through the first framefrom a top side of the first frame to a bottom side of the first frame,the first frame elements having a downward first adhesion surfaceincluding an adhesive material adapted to adhere the first adhesionsurface to the patient's skin; a first foil attached to the first frameand extending across the inner operation opening; and a fluid channelprovided in the first frame, the fluid channel being in fluidcommunication with a connector for injecting fluid into the fluidchannel, wherein the fluid channel opens into a space between the bottomside of the first frame and the first foil to allow flooding of a spacedefined between the first foil and the patient's skin if the first frameis attached to the patient's skin.
 20. The device according to claim 19,wherein the first foil comprises a removal extension for removing thefirst foil, the device further comprising: a second frame having secondframe elements encompassing a second inner operation opening, the secondframe having an outer dimension such that the second frame fits into thefirst frame, the second frame elements having a downward second adhesionsurface including an adhesive material adapted to adhere the secondadhesion surface to the patient's skin upon removal of the first foil;and a second foil, attached to the second frame and extending across thesecond inner operation opening.
 21. The device according to claim 20,wherein the second foil has a bottom surface facing towards the bottomside of the first frame, wherein the bottom surface is coated with afirst adhesive material adapted to attach the second foil to the skin ofthe patient, wherein an edge region of the second foil is reinforced oris coated with a second adhesive material having stronger adhesiveproperties than the first adhesive material.
 22. The device according toany of the preceding claim 19, wherein a second fluid channel isprovided in the first frame, the second fluid channel being in fluidcommunication with a second connector for removing fluid out of thesecond fluid channel, and wherein the second fluid channel opens intothe space between the bottom side of the first frame and the first foilto allow flooding of the space defined between the first foil and thepatient's skin if the first frame is attached to said patient's skin.23. The device according to claim 22, wherein the first fluid channelopens into the space on a first side of the frame and the second fluidchannel opens into the space on a second side of the frame which isopposite to the first side.
 24. The device according to claim 20,wherein the first foil or said second foil is attached to a collapsibleframe, wherein the collapsible frame in a first, upright conditiondefines side walls of a volume having a cross section generallycorresponding to the first or second inner operation opening,respectively, and wherein the collapsible frame can be collapsed to asecond condition, wherein the collapsible frame is lying flat on thefirst or second foil, respectively, and protects an edge region of thefoil against mechanical impact.
 25. A device for introducing sterileinstruments into an operation chamber or an instrument chambercomprising: an introduction frame attached to a first inflatable bag ofan isolation device for providing a sterile operation chamber above askin region of a patient, the first inflatable bag delimiting thesterile operation chamber against the ambient environment and comprisinga first and a second access opening to allow a user to insert a firstarm and a second arm into the operation chamber, and wherein the firstinflatable bag is coupled to a support frame having a transportconfiguration and an operation configuration, wherein while in thetransport configuration, the first inflatable bag is confined so as tohave compact dimensions, and while in the operation configuration, thefirst inflatable bag is extended to form the sterile operation chamber;a chamber operation opening to allow access to the skin region of thepatient; a window for observing handling operations inside the sterileoperation chamber; a first roller and a second roller arranged rotatablearound their respective longitudinal axis, and attached to theintroduction frame, wherein the longitudinal axis of the first rollerand the longitudinal axis of the second roller are parallel, and thefirst roller and the second roller are attached to the introductionframe so as to be movable along an axis extending perpendicular to theirrespective longitudinal axis, wherein a distance between the firstroller and the second roller is defined by a position of a movement ofthe first and second roller along the axis extending perpendicular totheir longitudinal axes, and wherein the first and second rollers arebiased to contact each other and the first and second roller aremoveable along the axis extending perpendicular to their longitudinalaxes to increase the distance to allow insertion of an instrumentthrough a gap defined by the distance; and an assisting device fordonning and removing a surgical glove arranged inside the firstinflatable bag, the assisting device comprising at least one fluid-tightwall arrangement encompassing an inner space having a volume of such asize that at least a palm portion and finger portions of the surgicalglove can be arranged in the inner space, and an opening adapted tosealingly engage a cuff portion of the surgical glove if the palmportion and the finger portions are arranged in the inner space, whereinthe fluid tight wall arrangement is adapted to be transformed from afirst configuration into a second configuration and vice-versa, wherein,while in the first configuration, the inner space has a first innervolume, and wherein, while in the second configuration, the inner spacehas a second inner volume, the first volume being smaller than thesecond volume.